Clinical Trial Associate (CTA)
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
This position is located in Conshohocken, PA.
The Clinical Trial Associate will provide support to the Clinical Operations team in the planning, execution, and management of clinical trials and programs. They will work collaboratively with the Immunocore Clinical Project Manager (CPM), Clinical Trial Manager (CTM), Clinical Research Organization (CRO) representative(s), vendors and other Immunocore functional departments (as required).
- Assist with review of Site Contracts, Site Budgets, and Site CDA's
- Evaluate and approve regulatory documents required for Local/Central IRB Submissions, EC Submissions, through investigational product greenlight/ release
- Assist in providing oversight & accountability to third party vendors assigned to a study or
- Ensure TMF Inspection readiness by:
- Assist with creation of TMF Index and TMF Plan, as needed
- Conduct periodic TMF document content review for completeness
- Ensure documents are filed in the correct locations and file naming conventions are correct
- Assist with quality reviews of TMF
- Assist in the archiving of study documentation for the TMF
- May help with coordination of Meetings, and responsible for Agendas, and Meeting Minutes
- Assist in tracking milestones, generating study metrics, and providing written and verbal updates to Management
- Liaise with Clinical Project Manager and/or others to resolve study related discrepancies and issues
- Post disclosure of trial information on publicly accessible websites (e.g., Clinicaltrials.gov)
- Ensure adherence to pertinent regulatory requirements and to departmental polices, practices and procedures. Ensure knowledge is kept up to date by reading SOP's and maintaining awareness of GCP guidelines
- Ensure program meets all GCP/ICH Guidelines and is Inspection Ready Essential
EXPERIENCE & KNOWLEDGE
- Good understanding of principles of a good clinical practice
- Industry experience in drug development with experience of early phase trials
- A proven track record of successfully contributing to the successful running of clinical study projects in a pharmaceutical/biotech business environment
- Able to work to high standards, and interact well with all professional levels
- Understand project specifications and applicable SOP's and able to fully understand and apply the principles of GCP
- IT literacy, particularly in Word, Excel and PowerPoint
- Ensure an enthusiastic and open attitude towards continuous professional development
- Knowledge and experience in Oncology therapeutic discipline
- Previous experience of working in Clinical Research or the Pharmaceutical Industry
- Previous exposure to eTMF systems
- Ability to support multiple trials and Programs
- Preferably educated to degree level (biological science, pharmacy or other health related discipline)
- At least 3 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO
- Experience must include global/international studies or programs
- Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant lmmunocore IRT and EDC systems and programs
Lead with Science and Discover What is Within:
- We value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Medical and vision benefits, beginning your first day of employment
- Fully paid Dental Insurance
- 20 days’ vacation plus holidays
- Fully paid Life Insurance and Disability
- 401(k) with Company Match
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.
Immunocore is an E-Verify employer.